RAPICIDE™ PA High Level Disinfectant

Issue

STERIS identified through customer complaints that a small number of RAPICIDE™ Part A bottles within certain lots may begin to bulge or expand over time. Part A is the active component of chemistry that creates peracetic acid, which may off-gas during the shelf-life of the product. Under routine conditions, the Part A bottle cap includes a vent intended to allow gas to escape (off-gassing) and reduce the potential for gas accumulation. If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.STERIS will provide a customer notification letter to all consignees who purchased affected lots. Consignees will be requested to follow the appropriate procedures and PPE needed to address any swollen bottles. The chemistry itself remains safe and effective to use in accordance with its labeling. However, replacement product will be provided for any product that had to be disposed.